Pancreatic Cancer
Conditions
Keywords
adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
Brief summary
RATIONALE: Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may help gemcitabine kill more tumor cells by making them more sensitive to the drug. PURPOSE: This phase II trial is studying how well giving 3-AP together with gemcitabine works in treating patients with recurrent, unresectable, or metastatic pancreatic cancer.
Detailed description
OBJECTIVES: Primary * Determine the antitumor activity of 3-AP (Triapine®) and gemcitabine, in terms of complete and partial response and 6-month progression-free disease, in patients with recurrent, unresectable, or metastatic pancreatic cancer. Secondary * Determine the objective response rates, median survival, 1-year survival rate, duration of response or stable disease, and progression-free survival of patients treated with this regimen. * Determine the safety and tolerability of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive 3-AP (Triapine®) IV over 2 hours and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response receive an additional 2 courses of therapy beyond response. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 28-50 patients will be accrued for this study within 7-13 months.
Interventions
DRUGgemcitabine hydrochloride
DRUGtriapine
Sponsors
National Cancer Institute (NCI)
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed pancreatic adenocarcinoma * Recurrent, unresectable, or metastatic disease * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * Prior radiation field must not have encompassed the only site of measurable disease * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 12 weeks Hematopoietic * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * No G6PD deficiency Hepatic * Bilirubin ≤ 1.5 times normal * AST and ALT ≤ 2.5 times upper limit of normal Renal * Creatinine ≤ 1.5 times normal OR * Creatinine clearance ≥ 60 mL/min Cardiovascular * No unstable angina pectoris * No cardiac arrhythmia * No symptomatic congestive heart failure Pulmonary * No severe pulmonary disease * No dyspnea at rest * No dependence on supplemental oxygen use Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study treatment * No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No other concurrent uncontrolled illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy except fluorouracil given as adjuvant therapy OR as a radiosensitizer during radiotherapy * More than 4 weeks since prior adjuvant fluorouracil therapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * See Chemotherapy * More than 4 weeks since prior radiotherapy and recovered Surgery * Not specified Other * No other concurrent investigational agents * No other concurrent anticancer therapy * No concurrent combination antiretroviral therapy for HIV-positive patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response (complete and partial) | Every 8 weeks for the duration of the trial, an expected average of 5 years |
| Prolonged stable disease rate | Stable disease of 6 or more months |
Secondary
| Measure | Time frame |
|---|---|
| Response duration | From date of response until progression |
| Median survival | For duration of trial, an expected average of 5 years |
| Safety and tolerability | Up to 1 year |
| Progression-free survival | From date of response until progression or death |
| Survival rate at 1 year | 1 year |
Countries
Canada
Outcome results
None listed